RAFASSAL 1 GRAM ENEMA

Israel - English - Ministry of Health

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Active ingredient:
MESALAZINE
Available from:
RAFA LABORATORIES LTD
ATC code:
A07EC02
Pharmaceutical form:
ENEMA
Composition:
MESALAZINE 1 G
Administration route:
RECTAL
Prescription type:
Required
Manufactured by:
RAFA LABORATORIES LTD, JERUSALEM
Therapeutic group:
MESALAZINE
Therapeutic area:
MESALAZINE
Therapeutic indications:
Treatment and prevention of ulcerative colitis and Crohn's disease.
Authorization number:
120 39 26001 00
Authorization date:
2014-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

18-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

Patient Leaflet According to the Pharmacists' Regulations (Preparations) - 1986

This medicine is sold with a doctor's prescription only

RAFASSAL ENEMA

1 gram, 4 grams

Active ingredient:

Each enema of Rafassal 1 gram contains: 1 gram of mesalazine.

Each enema of Rafassal 4 grams contains: 4 grams of mesalazine.

The active ingredient is also named mesalamine or 5-aminosalicylic acid.

For a list of inactive ingredients, please see section 6. See also 'Important information about some

of the medicine's ingredients' in section 2.

Read this entire leaflet carefully before using this medicine.

This leaflet contains concise information about the medicine. If you have any further questions,

refer to the doctor or pharmacist.

This medicine has been prescribed for treating your illness. Do not pass it on to others. It may

harm them, even if it seems to you that their illness is similar to yours.

1.

What is the medicine intended for?

The medicine is intended for the treatment and prevention of ulcerative colitis and Crohn’s

disease.

Therapeutic group: An anti-inflammatory medicine of the salicylate group.

2.

Before using the medicine

Do not use the medicine if:

Do not use if you are sensitive (allergic) to the active ingredient, salicylates such as aspirin, sulfite

(since this medicine contains potassium metabisulfite) or to any of the other ingredients this medicine

contains (for a list of inactive ingredients, please see section 6).

Do not use if you suffer from a severe impairment of liver or kidney function.

Special warnings regarding the use of this medicine:

During the treatment with this medicine, the doctor may decide to keep you under close medical

supervision (see also 'Tests and follow-up' in section 3).

If you are sensitive to any type of food or medicine, inform the doctor before using this

medicine.

Before starting the treatment with this medicine tell your doctor:

If you suffer or have suffered in the past from lung problems, especially if you suffer from

asthma.

If you suffer or have suffered in the past from allergy to a substance named sulphasalazine. In

such case, close medical supervision will be required. (If acute symptoms of intolerance appear,

such as: abdominal pain or cramps, bloody diarrhea, fever, headache, rash – stop the treatment

immediately).

If you suffer or have suffered in the past from problems related to liver function.

If you suffer or have suffered in the past from problems related to kidney/urinary system

function.

If you are taking or have recently taken any other medicines, including non-prescription

medicines and nutrition supplements, please tell your doctor or pharmacist. Especially inform

your doctor or pharmacist if you are taking the following medicines (it should be noted that the

following list mentions the active ingredients of the medicines. If you are unsure whether you are

using one of these medicines, please consult with your doctor or pharmacist):

Certain anticoagulants (such as warfarin).

Aspirin.

Azathioprine, 6 – mercaptopurine, thioguanine (medicines used to treat immune system

disorders).

Pregnancy and breast-feeding:

Do not use this medicine without consulting the doctor if you are pregnant.

Do not use this medicine without consulting the doctor if you are breastfeeding (the medicine

passes into breast milk).

Important information about some of the medicine’s ingredients:

The enema contains the preservative sodium benzoate, which may cause mild irritation of the skin,

eyes and mucous membranes.

Use in children:

There is no extensive experience in children. Use in children and adolescents age 6 to 18 years is

according to the doctor’s instructions and in accordance with their body weight.

3.

How to use this medicine?

Always use according to the doctor's instructions. Check with the doctor or pharmacist if you are

not sure.

The dosage, manner of treatment and duration of treatment will be determined by the doctor only.

Unless otherwise prescribed by your doctor, use the enema at bedtime.

Use this medicine at set intervals as determined by the attending doctor.

Do not exceed the recommended dose.

Attention:

Not to be swallowed! This medicine is intended for use through the anus.

Wait at least two hours between using this medicine and inserting any other medicine through the

anus.

Shake well before use.

How to use: See instructions for use and figures in section 7.

Tests and follow-up: Before starting the treatment and during it, you may be required to undergo blood

tests, urine tests and tests for liver and kidney functions.

If you have used an overdose or if a child has accidentally swallowed the medicine, proceed

immediately to a hospital emergency room and bring the package of the medicine with you.

If you forgot to use the medicine: If you forgot to use the enema at the set time, use it as soon

as you remember, but never use two doses together!

Continue with the treatment as recommended by the doctor.

Even if your state of health improves, do not stop the treatment with this medicine without

consulting your doctor.

Do not use or take medicines in the dark! Check the label and the dose each time you take a

medicine. Wear glasses if you need them.

If you have any further questions regarding the use of the medicine, consult the doctor or

pharmacist.

4.

Side effects

Like any medicine, the use of Rafassal enema may cause side effects in some users. If the side

effects persist or they are bothersome or get worse, consult your doctor. Do not be alarmed while

reading the list of side effects, you may not suffer from any of them.

Stop the treatment and refer to the doctor immediately in the following cases:

If angioedema or signs of hypersensitivity (allergy) appear, such as: fever, skin rash or

breathing difficulties.

If you suffer from very intense abdominal pain.

If you suffer from general unwell feeling , especially if accompanied by fever and/or sore mouth

or throat. In rare cases these symptoms may indicate a decrease in the number of white blood

cells (agranulocytosis), a condition which may cause you to be more susceptible to develop

severe infection.

Continue with the treatment and refer to the doctor immediately if anal irritation occurs.

Additional side effects:

Common side effects (appear in 1-10 users out of 100):

Abdominal pain, diarrhea, nausea, vomiting.

Rash and skin reactions (including urticaria, redness and skin inflammation).

Headache.

Rare side effects (appear in 1-10 users out of 10,000):

Flatulence.

Dizziness.

Chest pain, shortness of breath or swelling of the limbs as a result of an effect on the heart

(including inflammation of the heart muscle or heart membrane).

Changes in blood count.

Numbness and sensation of tingling in the hands and feet (peripheral neuropathy).

Allergic inflammation and/or other inflammatory conditions of the lungs, which may be

manifested, among other effects, by shortness of breath, cough, wheezing, a shadow in the

lungs seen on X-ray.

Inflammation of the pancreas which may be manifested by severe abdominal pain.

Liver function problems (including inflammation of the liver, cirrhosis, and liver failure).

Increase in amylase enzyme.

Change in urine color, changes in kidney function, sometimes accompanied by swelling of the

limbs or pain in the waist.

Lupus erythematosus like syndrome.

Very rare side effects (appear in less than one user out of 10,000):

Blood system disorders, such as anemia.

Increase in bilirubin.

Severe diarrhea and/or severe abdominal pain as a result of an inflammation or allergic reaction

of the bowel.

Severe skin reaction such as Erythema multiforme, Steven-Johnson syndrome.

Muscle and/or joint pains.

Hair loss, baldness.

Reversible decrease in sperm production.

Increase in the levels of liver enzymes (which is also reflected in blood tests).

Disorders of the liver and/or bile flow (for example, bile duct obstruction) which may cause

abdominal pain and/or jaundice (which may be manifested by yellowing of the skin and white of

the eye).

Side effects of unknown frequency (effects whose frequency has not yet been determined):

Increase in methemoglobin, anaphylactic reaction.

Local reactions in the anus may occur, such as itching, anal discomfort and bowel urgency.

In any case you experience side effects that are not mentioned in this leaflet or if there is a change

in your general feeling, consult the doctor immediately!

5.

How to store the medicine?

Avoid poisoning! This medicine, and any other medicine, must be stored in a safe place out of the

reach of children and/or infants, to avoid poisoning. Do not induce vomiting unless explicitly

instructed to do so by the doctor.

Do not use the medicine after the expiry date (exp. date) stated on the package. The expiry

date refers to the last day of that month.

Storage conditions: Store below 25˚C.

6.

Additional information

In addition to the active ingredient, the medicine also contains the following inactive

ingredients:

Potassium metabisulfite, potassium acetate, xantan gum, disodium edetate, sodium benzoate,

carbomer 934P, purified water.

What does the medicine look like and what does the package contain?

Color of the liquid in the enema bottle: beige/ light brown.

Each box contains 7 enemas of 60 grams each.

7.

Instructions of how to use the enema:

The best results will be achieved if the enema is performed immediately after bowel emptying.

1)

Preparation of the medicine for use:

Shake the bottle well to ensure homogeneity of the liquid.

Remove the protective cap from the applicator and hold the bottle by its neck to prevent

leakage (Figure 1).

2)

Correct position of the body:

The best results are achieved while lying on the left side, with the left leg straight and the

right leg bent forward for balance (Figure 2a).

Another option is: "knee-chest" position (Figure 2b).

3)

Administration of the enema:

Thoroughly clean and dry the rectal region (anus).

Gently insert the applicator, which is already lubricated, into the anus (rectum) while

directing it towards the navel.

Hold the bottle firmly and tilt it slightly, so that the applicator end is directed towards the

back and then slowly squeeze the bottle to insert the liquid inside (Figure 3). Steady

pressure of the hand will release most of the liquid. After use, discard the used bottle.

Stay in this position at least for the next 30 minutes to enable complete spreading of

the medicine in the intestine. If possible, use the enema at bedtime and hold the

liquid inside all night long.

Registration holder: Rafa Laboratories Ltd., P.O.Box 405, Jerusalem 9100301.

Medicine registration number in the National Medicines Registry of the Ministry of Health:

Rafassal enema 1 gram: 1203926001

Rafassal enema 4 grams: 0295825321

This leaflet was checked and approved by the Ministry of Health in May 2015.

056005

Rafassal

caplets, supp, enema -DL-May 2015-02

Doctor leaflet

Rafassal

Caplets, Suppositories, Enemas

Composition

Rafassal Caplets:

Active ingredient:

Rafassal 500 mg Caplets: Each caplet contains mesalazine (5-aminosalicylic acid) 500 mg.

Rafassal 1 gram Caplets: Each caplet contains mesalazine (5-aminosalicylic acid) 1000 mg

Inactive ingredients:

Sodium carbonate anhydrous, Glycine, Povidone K25, Cellulose microcrystalline, Sodium

carboxyl methyl cellulose, Silicon dioxide colloidal 200, Calcium stearate, Hydroxypropyl

methyl cellulose, Methacrilic acid copolymer (Eudragit L), Talc (micronized), Titanium dioxide,

Ferric oxide brown, Polyethylene glycol 6000, Simethicone emulsion, Sodium hydroxide

Rafassal Suppositories:

Active ingredient:

Rafassal 500 mg Suppositories :Each suppository contains mesalazine (5-aminosalicylic acid) 500 mg.

Rafassal 1 gram Suppositories :Each suppository contains mesalazine (5-aminosalicylic acid) 1000 mg.

Inactive ingredients:

Hard Fat W-45.

Rafassal Enemas:

Active ingredient:

Rafassal 1 gram Enema: Each enema (60 gram bottle) contains mesalazine (5-aminosalicylic acid) 1 gram.

Rafassal Enema 4 gram: Each enema (60 gram bottle) contains mesalazine (5-aminosalicylic acid ) 4 gram.

Inactive ingredients: Sodium benzoate, Carbomer 934P, Disodium edetate, Potassium

metabisulfite, Potassium acetate, Xanthan gum, Purified water.

Action

Pharmacotherapeutic group: Intestinal antiinflammatory agents; aminosalicylic acid and similar agents.

ATC code: A07EC02

Mechanism of action

The mechanism of the anti-inflammatory action is unknown. The results of in-vitro studies

indicate that inhibition of lipoxygenase may play a role.

Effects on prostaglandin concentrations in the intestinal mucosa have also been

demonstrated. Mesalazine (5-Aminosalicylic acid / 5-ASA) may also function as a radical

scavenger of reactive oxygen compounds.

Pharmacodynamic effects

Mesalazine, orally administered, acts predominantly locally at the gut mucosa and in the

submucous tissue from the luminal side of the intestine. It is important, therefore, that

mesalazine is available at the regions of inflammation. Systemic bioavailability / plasma

concentrations of mesalazine therefore are of no relevance for therapeutic efficacy, but

rather a factor for safety. In order to fulfil these criteria, Rafassal are coated with Eudragit

L; they are thus gastro-resistant and release of mesalazine is pH-dependent.

Rectally administered mesalazine:

On reaching the intestinal lumen, rectally administered mesalazine has largely local effects on

the intestinal mucosaand submucosal tissue.

Pharmacokinetic properties

General considerations of mesalazine:

Absorption:

Mesalazine absorption is highest in proximal gut regions and lowest in distal gut areas.

Biotransformation:

Mesalazine is metabolised both pre-systemically by the intestinal mucosa and the liver to the

pharmacologically inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). The acetylation

seems to be independent of the acetylator phenotype of the patient. Some acetylation also

occurs through the action of colonic bacteria. Protein binding of mesalazine and N-Ac-5-ASA

is 43% and 78%, respectively.

Elimination:

Mesalazine and its metabolite N-Ac-5-ASA are eliminated via the faeces (major part), renally

(varies between 20 and 50%, dependent on kind of application, pharmaceutical preparation

and route of mesalazine release, respectively), and biliary (minor part). Renal excretion

predominantly occurs as N-Ac-5-ASA.

About 1% of total orally administered mesalazine dose is excreted into the breast milk mainly

as N-Ac-5-ASA.

Orally administerd mesalazine:

Distribution:

Tablets reach the ileocoecal region after approximately 3-4 hours in fasting subjects and

reach the ascending colon within approximately 4–5 hours. The total transit time in the colon

is approximately 17 hours.

Absorption:

The release of mesalazine from caplets begins after a lag-phase of approximately 3–4 hours.

Peak plasma concentrations are reached after approximately 5 hours (ileocoecal region) and,

at 3 x 500 mg mesalazine/ day under steady-state conditions, are 3.0±1.6 µg/ml for

mesalazine and 3.4±1.6 µg/ml for the metabolite, N-Ac-5-ASA.

Elimination:

The total renal elimination rate for mesalazine and N-Ac-5-ASA over 24 hours during multiple

intake (3 x 500mg tablets, for 2 days; 1 tablet on the third day=examination day) was

approximately 60%. The non-metabolised mesalazine fraction after oral administration was

approximately 10%.

Indications

Treatment and prevention of ulcerative colitis and Crohn's disease.

Contraindications

Hypersensitivity to the active substance, salicylates or any of the excipients.

Severe impairment of liver and kidney function.

Warnings and Precautions

Mesalazine has occasionally been implicated in an acute intolerance syndrome. This

syndrome is characterized by abdominal cramps , acute abdominal pain and bloody diarrhea,

fever, severe headache and a rash. In such cases, prompt withdrawal is required. It is

important to be aware of this syndrome in patients who have already displayed intolerance to

sulfasalazine.

Patients with a history of adverse drug reactions to preparations containing

sulphasalazine should be kept under close medical surveillance on commencement of a

course of treatment with mesalazine.

Blood tests (differential blood count; liver function parameters such as ALT or AST; serum

creatinine) and urinary status (dip sticks) should be determined prior to and during treatment,

at the discretion of the treating physician. As a guideline, follow-up tests are recommended 14

days after commencement of treatment, then a further two to three tests at intervals of

4 weeks.

If the findings are normal, follow-up tests should be carried out every 3 months. If additional

symptoms occur, these tests should be performed immediately.

Caution is recommended in patients with impaired liver function.

Mesalazine is not recommended for use in patients with renal impairment. The renal function

should be monitored regularly (e.g. serum creatinine), especially during the initial phase of

treatment. Mesalazine induced nephrotoxicity should be suspected in patients developing

renal dysfunction during treatment.

Caution should be exercised in patients with elevated blood urea or proteinuria.

Patients with pulmonary disease, in particular asthma, should be very carefully monitored

during a course of treatment with mesalazine.

Mesalazine-induced cardiac hypersensitivity reactions (myo-and pericarditis) have rarely been

reported. Serious blood dyscrasias have very rarely been reported with mesalazine.

Haematological investigations should be performed if the patient develops unexplained

bleeding, bruising, purpura, anaemia, fever or sore throat.

In rare cases, in patients who have undergone bowel resection/bowel surgery in the

ileocoecal region with removal of the ileocoecal valve, it has been observed that tablets

contain mesalasine were excreted undissolved in the stool, due to an excessively rapid

intestinal passage.

Rafassal Enemas contain sodium benzoate, which may be mildly irritant to the skin, eyes

and mucous membranes.

Use in Pregnancy

There are no adequate and well-controlled studies in pregnant women.

However, data on a limited number of exposed pregnancies indicate no adverse effect of

mesalazine on pregnancy or on the health of the fetus/newborn child. To date no other

relevant epidemiologic data are available. In one single case after long-term use of a high

dose mesalazine (2-4 g, orally) during pregnancy, renal failure in a neonate was reported.

Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with

respect to pregnancy, embryonic/ fetal development, parturition or postnatal development.

Therefore mesalazine should only be used during pregnancy if the potential benefit outweighs

the possible risk.

Use in Breastfeeding

N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk.

Only limited experience during lactation in women is available to date. Hypersensitivity

reactions such as diarrhoea in the infant cannot be excluded. Therefore mesalazine should

only be used during breast-feeding if the potential benefit outweighs the possible risk. If the

infant develops diarrhoea, the breast-feeding should be discontinued

Use in Pediatrics

Infants and young children should not be treated with mesalazine unless it is strictly indicated,

or when alternative treatment is ineffective or unavailable.

Interference with Laboratory Tests

Use of mesalamine may lead to spuriously elevated test results when measuring urinary

normetanephrine by liquid chromatography with electrochemical detection, because of the

similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite,

Nacetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine

should be considered.

Drug Interactions

The concurrent use of mesalazine with other known nephrotoxic agents may increase the risk

of renal reaction

In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine,

a possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or

thioguanine should be taken into account.

There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.

Effects on ability to drive and use machines

No or negligible effects on the ability to drive and use machines have been observed.

Adverse Reactions

Mesalazine may be associated with an exacerbation of the symptoms of colitis in those

patients who have previously had such problems with sulphasalazine.

Undesirable effects are as follows:

Common

Gastrointestinal disorders:

1% and <10%)

Nausea, vomiting, diarrhoea, abdominal pain

Skin disorders:

Rash (including urticaria and erythematous rash)

General:

Headache

Rare

Blood and lymphatic system disorders:

0.01% and < 0.1%)

Altered blood counts (aplastic anaemia, agranulocytosis,

granulocytopenia, neutropenia, leukopenia, thrombocytopenia)

Nervous system disorders:

Peripheral neuropathy, dizziness

Cardiac disorders:

Myocarditis, pericarditis

Respiratory , thoracic and mediastinal disorders:

Allergic and fibrotic lung reactions (including dyspnoea, cough,

bronchospasm, alveolitis, pulmonary eosinophilia, pulmonary

infiltration, pneumonitis)

Gastrointestinal disorders:

Pancreatitis, increased amylase, flatulence

Liver:

Abnormalities of hepatic function and hepatotoxicity (including,

hepatitis, cirrhosis, hepatic failure)

Renal and urinary disorders :

Impairment of renal function (including acute and chronic

interstitial nephritis,

renal insufficiency, nephrotic syndrome),

urine discolouration (*see additional text)

Collagen disorders:

Lupus erythematosus

syndrome

Very rare

Blood disorders:

(<0.01% )

Anaemia, eosinophilia (as part of an systemic allergic reaction)

and pancytopenia

Hepatobiliary disorders :

Increased bilirubin.

Changes in liver function parameters (increase in

transaminases and parameters of cholestasis), cholestatic

hepatitis

Skin and subcutaneous tissue

disorders:

Alopecia, bullous skin reactions including erythema multiforme

and Stevens-Johnson syndrome

Musculoskeletal and connective tissue disorders:

Myalgia, arthralgia

Immune system disorders:

Hypersensitivity reactions

such as allergic exanthema

anaphylactic reaction, angioedema, drug fever,

pancolitis.

Reproductive system and breast disorders:

Oligospermia (reversible)

*Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in

patients developing renal dysfunction during treatment.

The mechanism of mesalazine-induced myocarditis, pericarditis, pancreatitis, nephritis and

hepatitis is unknown, but it might be of allergic origin.

Hypersensitivity reactions (which are not dose-related) such as allergic skin eruptions,

hyperpyrexia, bronchospasm and lupus erythematosus-like syndrome, cannot be excluded.

Theoretically, elevated methemoglobin levels may occur.

Mesalazine may be associated with the exacerbation of the symptoms of colitis in patients

who have previously had such problems when treated with sulfasalazine.

Following rectal administration local reactions such as pruritus, rectal discomfort and urge

may occur.

Dosage and Administration

During the acute inflammatory stage and in long-term maintenance therapy, Rafassal must be

taken reliably and consistently by the patient. This is essential in order to attain the desired

therapeutic success.

Rafassal Caplets

For acute inflammatory symptoms:

Individual dosage up to 4 gram/day, divided into 2 or 3 doses.

Rafassal caplets should be taken with an ample amount of fluid.

As soon as remission occurs, the dose should be reduced (to 2 g divided into 2 or 3 doses, to

avoid recurrence.

Children

There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older

Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided

doses. Maximum dose: 75 mg/kg/day. The total dose should not exceed the maximum adult

dose (4 grams).

Maintenance treatment (ulcerative colitis): To be determined individually, starting with

15-30 mg/kg/day in divided doses. The total dose should not exceed the recommended adult

dose (2 grams).

It is generally recommended that half the adult dose may be given to children up to a body

weight of 40 kg; and the normal adult dose to those above 40 kg.

Rafassal Suppositories

For acute inflammatory symptoms: 1 suppository of 500 mg 3 times daily. The suppositories

should be inserted deeply.

As soon as remission occurs, the dose should be reduced.

Rafassal Enemas

Dosage should be adjusted to the individual response to each patient.

Higher daily doses are recommended for acute disease episodes, with dose strength tapering

as disease remits.

Rectal suspensions of 5-aminosalicylic acid are best retained if administered at bedtime.

Optimal results are expected for those individuals retaining the medication during the entire

rest period.

Initiate therapy with bedtime administration of a 4 gram enema.

Response to therapy and adjustment of dosage should be determined by periodic

examination, including endoscopy and assessment of symptomatology, i.e. frequency of

bowel movements and rectal bleeding. The daily dosage should be tapered when a

significant response (improvement) or remission is attained. Abrupt withdrawal of therapy

without tapering to lower daily doses is not recommended.

Maintenance therapy is indicated to assure continued remission. The dosing schedule may be

every other day, every third day, or as required. The optimum maintenance dose should be

determined for each patient. If symptoms recur, dosage should be increased to the

previously effective level.

The 1 gram enema provides flexibility in dosing.

Overdose

There are rare data on overdosage (e.g. intended suicide with high oral doses of

mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote

and treatment is symptomatic and supportive.

Storage condition: Store below 25ºC.

Presentations and Registration Numbers:

Rafassal Caplets 500 mg:

0511126440

Rafassal Caplets 1 g:

0678028346

Rafassal 500 mg Suppositories: 0511226439

Rafassal Suppositories 1 g:

0695028345

Rafassal Enema 1 g:

1203926001

Rafassal Enema 4 g:

0295825321

Rafa Laboratories Ltd., P O Box 405, Jerusalem 9100301

The format and content of this document have been approved by the Ministry of Health in

May 2015.

לע העדוה לע העדוה ( הרמחה ( הרמחה עדימ עדימ )תוחיטב )תוחיטב :ךיראת

10

יאמב

2015

תילגנאב רישכת םש

:םושיר רפסמו

RAFASSAL CAPLETS 500MG

(

051 11 26440 00

),

RAFASSAL CAPLETS 1G

067 80

28346 00

RAFASSAL ENEMA 1G

120 39 26001 00),

RAFASSAL ENEMA 4G

(029 58 25321 00

RAFASSAL SUPPOSITORIES 500MG (

051 12 26439 00

),

RAFASSAL SUPPOSITORIES 1G

069 50 28345 00)

מ"עב אפר תודבעמ :םושירה לעב םש .עבצב םינמוסמ (הרמחה םג םיווהמ בור יפ לעש) םיייתועמשמה םייונישה

בוהצ ,הפסוה=

קורי .הקיחמ= אפורל ןולעב אפורל ןולעב ןולעב קרפ יחכונ טסקט שדח טסקט

Product Name

Rafassal

Tablets, Suppositories, Enemas

Rafassal

TabletsCaplets, Suppositories, Enemas

Composition

(inactives)

Rafassal Caplets

Inactive ingredients:

Sodium carbonate anhydrous, Glycine, Povidone

K25, Cellulose microcrystalline, Sodium carboxyl

methyl cellulose, Silicon dioxide colloidal 200,

Calcium stearate, Hydroxypropyl methyl cellulose,

Methacrilic acid copolymer (Eudragit L), Talc

(micronized), Titanium dioxide, Ferric oxide

brown, Polyethylene glycol 6000, Simethicone

emulsion, Sodium hydroxide

Rafassal Suppositories:

Inactive ingredients:

Hard Fat W-45

Rafassal Enemas

Inactive ingredients: Sodium benzoate,

Carbomer 934P, Disodium edentate, Potassium

metabisulfite, Potassium acetate, Xanthan gum,

Purified water

Contra-

indications

Known hypersensitivity to salicylates or

any of the excipients.

Severe disorders of liver and kidney

function, and in the presence of gastric

or duodenal ulcers.

Not to be used in patients where there

is a pathologically elevated tendency

to hemorrhage.

Hypersensitivity to the active substance, salicylates

or any of the excipients.

Severe disorders impairment of liver and kidney

function, and in the presence of gastric or duodenal

ulcers.

Not to be used in patients where there is a

pathologically elevated tendency to hemorrhage.

Warnings and

Precautions

Mesalazine has occasionally been

implicated in an acute intolerance

syndrome. This syndrome is

characterized by cramping, acute

abdominal pain and bloody diarrhea,

and sometimes, fever, headache and

a rash. In such cases, prompt

withdrawal is required. It is important

to be aware of this syndrome in

patients who have already displayed

intolerance to sulfasalazine

Caution is recommended in patients

with impaired liver function.

The drug is not recommended for use

Mesalazine has occasionally been implicated in an

acute intolerance syndrome. This syndrome is

characterized by cramping

abdominal cramps ,

acute abdominal pain and bloody diarrhea, and

sometimes, fever, severe headache and a rash. In

such cases, prompt withdrawal is required. It is

important to be aware of this syndrome in patients

who have already displayed intolerance to

sulfasalazine.

Patients with a history of adverse

drug reactions to preparations containing

sulphasalazine should be kept under close medical

surveillance on commencement of a course of

treatment with mesalazine.

Blood tests (differential blood count; liver function

parameters such as ALT or AST; serum creatinine)

in patients with renal impairment. The

renal function should be monitored

regularly (e.g. serum creatinine),

especially during the initial phase of

treatment. Mesalazine induced

nephrotoxicity should be suspected in

patients developing renal dysfunction

during treatment.

Caution should be exercised in

patients with elevated blood urea or

proteinuria.

Mesalazine-induced cardiac

hypersensitivity reactions (myo-and

pericarditis) have rarely been

reported. Serious blood dyscrasias

have very rarely been reported with

mesalazine. Haematological

investigations should be performed if

the patient develops unexplained

bleeding, bruising, purpura, anaemia,

fever or sore throat

Use in Pregnancy

There are no adequate and well-

controlled studies in pregnant

women. Therefore Rafassal should

be used during pregnancy only if

clearly needed

Use in Breastfeeding

Low concentrations of mesalamine and

higher concentrations of its N-acetyl

metabolite have been detected in

human breast milk. While the clinical

significance of this has not been

determined, caution should be

exercised when mesalamine is

administered to a nursing woman.

Use in Pediatrics

Infants and young children should not

be treated with this drug unless it is

strictly indicated, or when alternative

treatment is ineffective or unavailable.

and urinary status (dip sticks) should be determined

prior to and during treatment, at the discretion of the

treating physician. As a guideline, follow-up tests

are recommended 14 days after commencement of

treatment, then a further two to three tests at

intervals of 4 weeks.

If the findings are normal, follow-up tests should

be carried out every 3 months. If additional

symptoms occur, these tests should be performed

immediately.

Caution is recommended in patients with impaired

liver function.

Mesalazine is not recommended for use in patients

with renal impairment. The renal function should be

monitored regularly (e.g. serum creatinine),

especially during the initial phase of treatment.

Mesalazine induced nephrotoxicity should be

suspected in patients developing renal dysfunction

during treatment.

Caution should be exercised in patients with

elevated blood urea or proteinuria.

Patients with pulmonary disease, in particular

asthma, should be very carefully monitored during a

course of treatment with mesalazine.

Mesalazine-induced cardiac hypersensitivity

reactions (myo-and pericarditis) have rarely been

reported. Serious blood dyscrasias have very rarely

been reported with mesalazine. Haematological

investigations should be performed if the patient

develops unexplained bleeding, bruising, purpura,

anaemia, fever or sore throat.

In rare cases, in patients who have undergone

bowel resection/bowel surgery in the ileocoecal

region with removal of the ileocoecal valve, it has

been observed that tablets contain mesalasine

were excreted undissolved in the stool, due to an

excessively rapid intestinal passage.

Rafassal Enemas contain sodium benzoate, which

may be mildly irritant to the skin, eyes and mucous

membranes.

Use in Pregnancy

There are no adequate and well-controlled studies

in pregnant women.

However, data on a limited number of exposed

pregnancies indicate no adverse effect of

mesalazine on pregnancy or on the health of the

fetus/newborn child. To date no other relevant

epidemiologic data are available. In one single case

after long-term use of a high dose mesalazine (2-4

g, orally) during pregnancy, renal failure in a

neonate was reported.

Animal studies on oral mesalazine do not indicate

direct or indirect harmful effects with respect to

pregnancy, embryonic/ fetal development,

parturition or postnatal development.

Therefore mesalazine should be used during

pregnancy only if clearly needed should only be

used during pregnancy if the potential benefit

outweighs the possible risk.

Use in Breastfeeding

Low concentrations of mesalamine and higher

concentrations of its N-acetyl metabolite have been

detected in human breast milk. While the clinical

significance of this has not been determined,

caution should be exercised when mesalamine is

administered to a nursing woman.

N-acetyl-5-aminosalicylic acid and to a lesser

degree mesalazine are excreted in breast milk. Only

limited experience during lactation in women is

available to date. Hypersensitivity reactions such as

diarrhoea in the infant cannot be excluded.

Therefore mesalazine should only be used during

breast-feeding if the potential benefit outweighs the

possible risk. If the infant develops diarrhoea, the

breast-feeding should be discontinued

Use in Pediatrics

Infants and young children should not be treated

with mesalazine unless it is strictly indicated, or

when alternative treatment is ineffective or

unavailable.

Interference with Laboratory Tests

Use of mesalamine may lead to spuriously elevated

test results when measuring urinary

normetanephrine by liquid chromatography with

electrochemical detection, because of the similarity

in the chromatograms of normetanephrine and

mesalamine’s main metabolite,

Nacetylaminosalicylic acid (N-Ac-5-ASA). An

alternative, selective assay for normetanephrine

should be considered.

Drug

Interactions

The hypoglycemic effect of

sulfonylureas may be enhanced.

Interaction may occur with coumarin

derivatives.

Rafassal tablets may intensify the

undesirable effects of glucocorticoids

on the stomach.

Concurrent administration of lactulose

and products which may decrease

stool pH may prevent release of the

drug.

The concurrent use of mesalazine with

other known nephrotoxic agents, such

as NSAIDs and azathioprine, may

increase the risk of renal reaction

Concomitant treatment with

mesalazine can increase the risk of

blood dyscrasia in patients receiving

azathioprine or 6-mercaptopurine.

Treatment should be discontinued on

suspicion or evidence of these adverse

reactions.

Concurrent administration with other

The hypoglycemic effect of sulfonylureas may be

enhanced.

Interaction may occur with coumarin derivatives.

Rafassal tablets may intensify the undesirable

effects of glucocorticoids on the stomach.

Concurrent administration of lactulose and products

which may decrease stool pH may prevent release

of the drug.

The concurrent use of mesalazine with other known

nephrotoxic agents, such as NSAIDs and

azathioprine, may increase the risk of renal reaction

Concomitant treatment with mesalazine can

increase the risk of blood dyscrasia in patients

receiving azathioprine or 6-mercaptopurine.

Treatment should be discontinued on suspicion or

evidence of these adverse reactions.

Concurrent administration with other inflammatory

bowel disease products may intensify undesirable

effects.

In patients who are concomitantly treated with

azathioprine, 6-mercaptopurine or thioguanine, a

possible increase in the myelosuppressive effects of

inflammatory bowel disease products

may intensify undesirable effects.

azathioprine, 6-mercaptopurine or thioguanine

should be taken into account.

There is weak evidence that mesalazine might

decrease the anticoagulant effect of warfarin.

Effects on

ability to

drive and use

machines

Effects on ability to drive and use machines

No or negligible effects on the ability to drive and

use machines have been observed.

Adverse

Reactions

Rare (

0.01% and < 0.1%)

Blood disorders:

Aplastic anaemia, agranulocytosis,

granulocytopenia, neutropenia,

leukopenia, thrombocytopenia

Nervous system disorders:

Peripheral neuropathy

Cardiac disorders:

Myocarditis, pericarditis

Respiratory disorders:

Allergic lung reactions (including

dyspnoea, cough, allergic alveolitis,

pulmonary eosinophilia, pulmonary

infiltration, pneumonitis)

Gastrointestinal disorders:

Pancreatitis, increased amylase,

Liver:

Abnormalities of hepatic function and

hepatotoxicity (including, hepatitis,

cirrhosis, hepatic failure)

Urogenital:

Abnormal

renal function (including

interstitial nephritis, nephrotic

syndrome), urine discolouration (*see

additional text)

Collagen disorders:

Lupus erythematosus-like reactions

Very rare (<0.01% )

Blood disorders:

Anaemia, eosinophilia (as part of an

allergic reaction**) and pancytopenia

Rare (

0.01% and < 0.1%)

Blood and lymphatic system disorders:

Altered blood counts (aplastic anaemia,

agranulocytosis, granulocytopenia, neutropenia,

leukopenia, thrombocytopenia)

Nervous system disorders:

Peripheral neuropathy, dizziness

Cardiac disorders:

Myocarditis, pericarditis

Respiratory , thoracic and mediastinal disorders:

Allergic and fibrotic lung reactions (including

dyspnoea, cough,

bronchospasm, allergic alveolitis,

pulmonary eosinophilia, pulmonary infiltration,

pneumonitis)

Gastrointestinal disorders:

Pancreatitis, increased amylase, flatulence

Liver:

Abnormalities of hepatic function and hepatotoxicity

(including, hepatitis, cirrhosis, hepatic failure)

Renal and urinary disorders Urogenital:

Abnormal

Impairment of renal function (including

acute and chronic interstitial nephritis,

renal

insufficiency, nephrotic syndrome), urine

discolouration (*see additional text)

Collagen disorders:

Lupus erythematosus-like reactions

syndrome

Very rare (<0.01% )

Blood disorders:

Anaemia, eosinophilia (as part of an systemic

allergic reaction) and pancytopenia

Liver

Hepatobiliary disorders :

Liver :

Increased liver enzymes and bilirubin.

Skin disorders:

Reversible Alopecia, bullous skin

reactions including erythema

multiforme and Stevens-Johnson

syndrome**

Musculoskeletal disorders:

Myalgia, arthralgia

Allergic reactions:

Hypersensitivity reactions

drug fever,.

Hypersensitivity reactions (which are

not dose-related) such as allergic skin

eruptions, hyperpyrexia,

bronchospasm and lupus

erythematosus-like syndrome, cannot

be excluded.

Increased liver enzymes and bilirubin.

Changes in liver function parameters (increase in

transaminases and parameters of cholestasis),

cholestatic hepatitis

Skin and subcutaneous tissue

disorders:

Reversible Alopecia, bullous skin reactions

including erythema multiforme and Stevens-

Johnson syndrome

Musculoskeletal and connective tissue disorders:

Myalgia, arthralgia

Immune system disorders Allergic reactions:

Hypersensitivity reactions

such as allergic

exanthema, anaphylactic reaction, angiedema, drug

fever,

pancolitis.

Reproductive system and breast disorders:

Oligospermia (reversible)

Hypersensitivity reactions (which are not dose-

related) such as allergic skin eruptions,

hyperpyrexia, bronchospasm and lupus

erythematosus-like syndrome, cannot be excluded.

Theoretically, elevated methemoglobin levels may

occur.

Mesalazine May be associated with the

exacerbation of the symptoms of colitis in patients

who have previously had such problems when

treated with sulfasalazine.

Following rectal administration local reactions such

as pruritus, rectal discomfort and urge may occur.

Dosage and

Administra-

tion

Rafassal Caplets

For acute inflammatory symptoms:

Individual dosage up to 4 gram/day,

divided into 3 doses..

Rafassal tablets should be taken with

food or after meals with an ample

amount of fluid.

As soon as remission occurs, the dose

should be reduced (to 1.5g into 3

doses, to avoid recurrence.

The patient should wait at least 2

hours between taking this drug and

other drugs that may affect

gastrointestinal acidity (e.g.omeprazole

and antacids)

Children: Individual dosage, starting

with 50 mg/kg bodyweight daily in

divided doses.

Rafassal Suppositories

For acute inflammatory symptoms: 1

suppository of 500 mg 3 times daily.

The suppositories should be inserted

deeply.

As soon as remission occurs, the dose

should be reduced to 1 suppository of

Rafassal 250 mg 3 times daily to avoid

recurrence.

Rafassal Enemas…

Rafassal Caplets

For acute inflammatory symptoms:

Individual dosage up to 4 gram/day, divided into 2

3 doses.

Rafassal caplets should be taken with food or after

meals with an ample amount of fluid.

As soon as remission occurs, the dose should be

reduced (to 1.5g 2 g divided into 2 or

3 doses, to

avoid recurrence.

The patient should wait at least 2 hours between

taking this drug and other drugs that may affect

gastrointestinal acidity (e.g.omeprazole and

antacids)

Children: Individual dosage, starting with 50 mg/kg

bodyweight daily in divided doses.

Children

There is only limited documentation for an effect in

children (age 6-18 years).

Children 6 years of age and older

Active disease: To be determined individually,

starting with 30-50 mg/kg/day in divided doses.

Maximum dose: 75 mg/kg/day. The total dose

should not exceed the maximum adult dose.

Maintenance treatment (ulcerative colitis): To be

determined individually, starting with 15-30

mg/kg/day in divided doses. The total dose should

not exceed the recommended adult dose.

It is generally recommended that half the adult dose

may be given to children up to a body weight of 40

kg; and the normal adult dose to those above 40 kg.

Rafassal Suppositories

For acute inflammatory symptoms: 1 suppository of

500 mg 3 times daily. The suppositories should be

inserted deeply.

As soon as remission occurs, the dose should be

reduced to 1 suppository of Rafassal 250 mg 3

times daily to avoid recurrence.

Rafassal Enemas…

Overdose

Acute experience in animals:

Single oral doses of

mesalazine up to 5 g/kg in pigs

or single intravenous dose of

mesalazine at 920 mg/kg in

rats were not lethal.

Human experience: No cases

of overdose have been

reported.

Management of overdose in

man: Symptomatic treatment

(at hospital). . Close

monitoring of renal function.

There are rare data on overdosage (e.g.

intended suicide with high oral doses of

mesalazine), which do not indicate renal or

hepatic toxicity. There is no specific antidote and

treatment is symptomatic and supportive.

Acute experience in animals: Single oral

doses of mesalazine up to 5 g/kg in pigs or

single intravenous dose of mesalazine at

920 mg/kg in rats were not lethal.

Human experience: No cases of overdose

have been reported.

Management of overdose in man:

Symptomatic treatment (at hospital). . Close

monitoring of renal function.

ןכרצל ןולעב ןכרצל ןולעב

דבלב ןקוח לאסאפר רובע ןולעב קרפ יחכונ טסקט שדח טסקט תדעוימ המל הפורתה

תיתקלד-יטנא הפורת

תדעוימ הפורתה יעמב תיביכ תקלד לש העינמלו לופיטל ) סגה

ulcerative colitis

.ןהורק תלחמ לשו תיביכ תקלד לש העינמלו לופיטל תדעוימ הפורתה ) סגה יעמב

ulcerative colitis

ןהורק תלחמ לשו שמתשהל ןיא םא הפורתב תושיגר העודי םא רישכתב שמתשהל ןיא וא ,םירחא םיטליצילסל ,ויביכרממ דחאל םויסטופ ליכמ הז רישכתש ןוויכמ טיפלוסל טיפלוסיב הטמ

םיטליצילסל ,ליעפה רמוחל (יגרלא) שיגר התא ,ןיריפסא תמגודכ הז רישכתש ןוויכמ) טיפלוסל דחא לכל וא ,(טיפלוסיב הטמ םויסטופ ליכמ רישכתה ליכמ רשא םיפסונה םיביכרמהמ ףיעס האר ,םיליעפ יתלבה םיביכרמה תמישרל)

דוקפתב רומח יוקלמ לבוס התא םא שמתשהל ןיא .תוילכה וא דבכה תורהזא תודחוימ תועגונה שומישל הפורתב הפורתל וא והשלכ ןוזמל שיגר ךניה םא ךילע ,(ןיזאלסאפלוסל דחוימב) יהשלכ .הפורתה תליטנ ינפל אפורל ךכ-לע עידוהל ךורעל שי

הפורתב לופיטה תפוקתב .תוילכ ידוקפתו ןתש ,םד תוקידב

לע טילחי אפורהו ןכתיי ,הפורתב לופיטה ךלהמב ףיעסב 'בקעמו תוקידב' םג האר) דומצ יאופר בקעמ

,יהשלכ הפורתל וא והשלכ ןוזמל שיגר התא םא הפורתה תליטנ ינפל אפורל ךכ-לע עידוהל ךילע תלחתה ינפל רפס לופיטה ךלש אפורל .הקינימ וא ןוירהב ךניה םא יוקילמ רבעב תלבס וא לבוס ךניה םא ,ןתשה תכרעמ/הילכה ,דבכה :דוקפתב תכרעמ ,(יטפפ ביכ ןוגכ) לוכיעה תכרעמ ('וכו השירק ןוגכ) םדה

.

דחוימב ,תואיר תויעבמ רבעב תלבס וא לבוס התא םא .המטסאמ לבוס התא םא

םשב רמוחל היגרלאמ רבעב תלבס וא לבוס התא םא ) ןיזלאסאפלוס

sulphasalazine

שרדת ,הזכ הרקמב םינימסת םיעיפומו הדימב) .הדומצ תיאופר החגשה ,ןטבב תותיווע וא םיבאכ :ןוגכ ,תוליבס יא לש םיטוקא תא קיספהל שי - החירפ ,שאר באכ ,םוח ,ימד לושלש .(דימ לופיטה

.דבכה דוקפתב תויעבמ רבעב תלבס וא לבוס התא םא

דוקפתב תויעבמ רבעב תלבס וא לבוס התא םא .ןתשה תכרעמ/הילכה תכרעמ:דוקפתב יוקילמ רבעב תלבס וא לבוס ךניה םא השירק ןוגכ) םדה תכרעמ ,(יטפפ ביכ ןוגכ) לוכיעה ('וכו

.

התא םא םא וא חקול תחקל תופורת תורחא :תויתפורת ןיב תובוגת ללוכ ,תופסונ תופורת לטונ ךניה םא יפסותו םשרמ אלל תורכמנה תופורת לופיט התע הז תמייס םא וא ,הנוזת אפורל חוודל ךילע ,תרחא הפורתב תוליעי-יא וא םינוכיס עונמל ידכ לפטמה דחוימב ,תויתפורת-ןיב תובוגתמ םיעבונה ,ןיריפסא :תואבה תוצובקהמ תופורת יבגל תולשלשמ תופורת ,םד תשירק דגנ תופורת יעמה תולחמב לופיטל תופסונ תופורתו .סגה ,תורחא תופורת הנורחאל תחקל םא וא חקול התא םא ךכ לע רפס ,הנוזת יפסותו םשרמ אלל תופורת ללוכ .חקורל וא אפורל חקורה וא אפורה תא עדייל שי דחוימב המישרה יכ ןייצל שי) תואבה תופורתה תא חקול התא םא ךניא םא .תופורתב םיליעפה םירמוחה תא תנייצמ ןלהלש אנא וללה תופורתהמ תחאב שמתשמ התא םאה חוטב :(חקורה וא אפורה םע ץעייתה

םד תשירק דגנ תומיוסמ תופורת .(ןירפרו ןוגכ)

.ןיריפסא

,ןירפויתזא

תופורת) ןינאוגוית ,ןירוטפקרמ- .(תינוסיחה תכרעמב תוערפהב לופיטל תושמשמה וא םינוכיס עונמל ידכ לפטמה אפורל חוודל ךילע יבגל דחוימב ,תויתפורת-ןיב תובוגתמ םיעבונה תוליעי-יא :תואבה תוצובקהמ תופורת

תופורתו תולשלשמ תופורת

.סגה יעמה תולחמב לופיטל תופסונ הקינמו ןוירה ץעוויהל ילבמ רישכתב שמתשהל ןיא םירקמב לופיטה תלחתה ינפל אפורב :םיאבה

הקינימ וא ןוירהב ךניה םא

הקנהו ןוירה

.ןוירהב תא םא אפורה םע ץעייתהל ילבמ הפורתב שמתשהל ןיא

הקינמ תא םא אפורה םע ץעייתהל ילבמ הפורתב שמתשהל ןיא .(םא בלחב תרבוע הפורתה) :הפורתה לש םיביכרמהמ קלח לע בושח עדימ םורגל לולעה ,טאוזנב םוידוס רמשמה תא ליכמ ןקוחה .תוירירה תונרבממבו םייניעב ,רועב לק יוריגל שומיש םידליב :ןונימ רובעל ןיא .דבלב אפורה תוארוה יפל ןונימ .תצלמומה הנמה לע םידליל ללכ ךרדב תדעוימ הניא וז הפורת .אפור תארוה יפ לע אלא

:םידליב שומיש

שומישה .םידליב שומישב בר ןויסינ ןיא יאליגב םירגבתמו םידליב

דע

תוארוה יפל אוה .םפוג לקשמל םאתהבו אפורה

תדעוימ הניא וז הפורת .אפור תארוה יפ לע אלא םידליל ללכ ךרדב דציכ שמתשת ?הפורתב :ןונימ רובעל ןיא .דבלב אפורה תוארוה יפל ןונימ .תצלמומה הנמה לע :תורהזא הפורתל וא והשלכ ןוזמל שיגר ךניה םא ךילע ,(ןיזאלסאפלוסל דחוימב) יהשלכ .הפורתה תליטנ ינפל אפורל ךכ-לע עידוהל ךורעל שי

הפורתב לופיטה תפוקתב .תוילכ ידוקפתו ןתש ,םד תוקידב

,ןונימה לופיטה ךשמו לופיטה ןפוא אפורה ידי לע ועבקיי .דבלב

בקעמו תוקידב

לופיטה תליחת ינפל ןכתיי וכלהמבו ןתש ,םד תוקידב רובעל ךרטצתו

ידוקפתו דבכ ו .תוילכ יאוול תועפות ןמזב ,הפורתה לש היוצרה תוליעפל ףסונב יאוול תועפות עיפוהל תולולע הב שומישה ,ןטב יבאכ ,האקה ,הליחב ,לושלש :ןוגכ .השלוח ,שאר באכ ןהש וא תופלוח ןניא יאוולה תועפות םא .אפורה םע ץעייתהל שי ,תודירטמ תדחוימ תוסחייתה תובייחמה תועפות

:

לושלש ללוכ ,רתי תושיגר ינמיס עיפוהב םיקזח ןטב יבאכ ,רועב החירפ ,םוח ,ימד אפורל הנפו לופיטה קספה - (רידנ) דואמ !דימ הנפו לופיטה ךשמה – תעבטה יפב יוריג !דימ אפורל יאוול תועפות שיגרמ ךניה ובש הרקמ לכב יוניש לח םא וא ,הז ןולעב וניוצ אלש םע ץעייתהל ךילע תיללכה ךתשגרהב !דימ אפורה הב שומישה ןמזב ,הפורתה לש היוצרה תוליעפל ףסונב :ןוגכ יאוול תועפות עיפוהל תולולע

השלוח

םורגל לולע לאסאפר ןקוחב שומישה ,הפורת לכב ומכ יאוולה תועפות םא .םישמתשמהמ קלחב יאוול תועפותל שי ,תורימחמ ןהש וא תודירטמ ןהש וא תופלוח ןניא תועפות תמישר ארקמל להבית לא .אפורה םע ץעייתהל .ןהמ תחא ףאמ לובסת אלו ןכתי ,יאוולה :םיאבה םירקמב דימ אפורל הנפו לופיטה קספה

עיפוהב וא המדאויגנא

רתי תושיגר ינמיס (היגרלא)

ןוגכ

דואמ םיקזח ןטב יבאכ ,רועב החירפ ,םוח

יישק וא .המישנ

הוולמה וזכ דחוימב ,הער תיללכ השגרהמ לבוס התא םא הלא םינימסת תורידנ םיתעל .ןורגב וא הפב םיבאכ וא/ו םוחב םינבלה םדה יאת רפסמב הדירי לע דיעהל םילולע רתוי שיגר תויהל ךל םורגל לולעה בצמ ,(סיזוטיצולונרגא) .רומח םוהיז חתפל עיפוהב דימ אפורל הנפו לופיטה ךשמה יפב יוריג .תעבטה :תופסונ יאוול תועפות -ב תועיפומ( תוחיכש יאוול תועפות

1-10

םישמתשמ ךותמ

100

:)

.תואקה ,תוליחב ,םילושלש ,ןטב באכ

תקלדו םדוא ,הירקיטרוא ללוכ) תוירוע תובוגתו החירפ .(רועב

.שאר באכ -ב תועיפומ( תורידנ יאוול תועפות

1-10

םישמתשמ ךותמ

10,000

:)

.תרוחרחס ,םיזג

האצותכ םייפגה תוחפנתה וא המישנ רצוק ,הזחב באכ םורקב וא בלה רירשב תקלד ללוכ) בלה לע העפשהמ .(בלה

.םד תריפסב םייוניש

היתפוריונ) םילגרבו םיידיב ץוצקעו השוחת רסוח .(תיפקיה

,תואירה לש םירחא םייתקלד םיבצמ וא/ו תיגרלא תקלד

,לועיש ,המישנ רצוקב ראשה ןיב אטבתהל םילוכיש .ןגטנרב הארנה תואירב לצ ,המישנב םיפוצפיצ

.רומח ןטב באכב אטבתהל הלוכיש בלבלב תקלד

תבהצ (ןיעה ןבולו רועה לש הבהצהב אטבתהל הלוכיש) תמירזב וא/ו דבכב םייוקילמ האצותכ ןטב באכ וא/ו .(םד תוקידבב םג םיאטבתמש) הרמה

.זלימע םיזנאה לש הילע

םיוולמה ,תוילכה ידוקפתב םייוניש ,ןתשה עבצב יוניש .םיינתומב באכ וא םייפגה תוחפנתהב םיתיעל

.(סופול) תיתנמדא תבאז תיומד תנומסת שמתשממ תוחפב תועיפומ( דואמ תורידנ יאוול תועפות ךותמ דחא

10,000

:)

.הימנא ןוגכ םדה תכרעמב תוערפה

.ןיבוריליב לש הילע

וא תקלדמ האצותכ רומח ןטב באכ וא/ו רומח לושלש .יעמה לש תיגרלא הבוגת

ןוגכ הרומח תירוע הבוגת

Erythema multiforme

תנומסת

Steven-Johnson

.םיקרפמ וא/ו םירירש יבאכ

.תוחרקתה ,רעיש תרישנ

.ערזה רוצייב הכיפה הדירי תועפות

יאוול

ןתוחיכשש

הניא

העודי

)

תועפות

ןתוחיכשש םרט

העבקנ

(:

.תיטקליפאנא הבוגת ,ןיבולגומהתמב הילע

יא ,דרג ןוגכ תעבטה יפב תוימוקמ תובוגת ונכתיי .האיציל תופיחדו תעבטה יפב תוחונ וניוצ אלש יאוול תועפות שיגרמ ךניה ובש הרקמ לכב ךילע תיללכה ךתשגרהב יוניש לח םא וא ,הז ןולעב דימ אפורה םע ץעייתהל

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